The aim of this study is to assess disintegration of the new Aspirin disintegrating tablets
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
12
Single intake of 1 tablet, 500mg
Single intake of 1 tablet, 1000mg
Single intake of 1 tablet, 400mg
Bio-Images Research Ltd
Glasgow, Glasgow City, United Kingdom
Time to complete tablet disintegration
The tablet is radiolabeled. Scintigraphy images of the abdominal area will be taken It is time until an image with no definable hot spot remaining is identified
Time frame: Up to 4 hours
Gastric empty time, if applicable
Gastric emptying time will be calculated by a qualified assessor based on the scintigraphy images
Time frame: Up to 4 hours
Time of colon arrival, if applicable
Time of colon arrival will be calculated by a qualified assessor based on the scintigraphy images
Time frame: Up to 4 hours
Small intestine transit time, if applicable
Small intestine transit time will be calculated by a qualified assessor based on the scintigraphy images
Time frame: Up to 4 hours
Time of onset of release of radiolabel
Time of onset of release of radiolabel will be calculated by a qualified assessor based on the scintigraphy images
Time frame: Up to 4 hours
Site of onset of release of radiolabel
Site of onset of release of radiolabel will be determined by a qualified assessor based on the scintigraphy images
Time frame: Up to 4 hours
Site of completion of release of radiolabel
Site of completion of release of radiolabel will be determined by a qualified assessor based on the scintigraphy images
Time frame: Up to 4 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Single intake of 1 tablet, 400mg
Disintegration rate of the tablet estimated from the radioactivity remaining
Disintegration rate of the tablet estimated from the radioactivity rem will be calculated by a qualified assessor based on the scintigraphy images
Time frame: Up to 4 hours
Time of 50% disintegration of the tablet estimated from the radioactivity remaining
Time of 50% disintegration of the tablet estimated from the radioactivity remaining will be calculated by a qualified assessor based on the scintigraphy images
Time frame: Up to 4 hours
Gastric emptying kinetics of dispersed radioactive material (t50% and t90%)
Gastric emptying kinetics of dispersed radioactive material (t50% and t90%) will be calculated by a qualified assessor based on the scintigraphy images
Time frame: Up to 4 hours
AUC0-t
Area under the plasma concentration vs time curve from zero to the last data point
Time frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Cmax
Maximum drug concentration in plasma after single dose administration
Time frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
AUC0-infinity
Area under the plasma concentration vs time curve from zero to infinity
Time frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
t1/2
Half-life associated with the terminal slope
Time frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
tmax
Time to reach maximum drug concentration in the measured
Time frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose
Cmax/AUC0-infinity
Time frame: Prior to dosing (between 60-15 min), and 5, 9, 13, 18, 23, 28, 33, 38, 48, 58, 68, 78, 88, 118, 178 and 238 min post-dose